Multicentre, randomised, double-blind, placebo-controlled study of the efficacy and safety of Broncho-Vaxom in adults suffering from chronic rhinosinusitis - Broncho-Vaxom in adults suffering from chronic rhinosinusitis

• Conditions: chronic rhinosinusitis; MedDRA version: 9.1Level: LLTClassification code 10052106Term: Rhinosinusitis

• Registration Number: EUCTR2007-005152-16-AT
• Lead Sponsor: OM PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-05
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- patients of either sex aged 18 - 75
- patients must experience a facial pain especially unilaterally; and at least one of the two following symptoms (> 50 % of days in the last 3 months):
more than 12 consecutive weeks of symptomatic nasal obstruction and/or more than 12 weeks of symptomatic nasal discharge
- an otorhinolaryngologist (ENT) evaluation and diagnosis of chronic inflammatory rhinosinusitis (hyperplastic mucosa, nasal polyps) and either endoscopic signs and/or CT
-patients having given their written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- sinus surgery within the last 3 months
- acute illness within the last 2 weeks requiring antibiotics
- immunosuppression
- sinister signs requiring intermediate intervention
- serious concomitant disease, which might interfere with or modify the outcome
- patients with acute bacterial rhinosinusitis as increase of symptoms after 5 days or persistent symptoms after 10 days with less than 12 weeks duration
- patients under immunosuppressive or immunostimulating therapy within 1 month prior to study start
- patients under systemic corticosteroid therapy within 1 month prior to study start with a regular oral corticosteroids > 10 mg of prednisolone more than 2 weeks
- patients with a known allergy or previous intolerance or known hypersensitivity to the trial drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of Broncho-Vaxom in adults suffering from chronic rhinosinusitis.;Secondary Objective: To evaluate the efficacy and safety of Broncho-Vaxom concerning the time until patient is asymptomatic and consumption of rescue medication (antibiotics, analgetics and topical corticosteroids) in comparison to Placebo.;Primary end point(s): Comparisons between the two groups of severity of rhinosinusitis (SNOT-20) during the trial (AUC).